A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
Information source: Mundipharma Research Limited
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Caner Pain
Intervention: Oxycodone Hydrochloride (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mundipharma Research Limited Overall contact:
Jill Kiteley, Email: info@contact-clinical-trials.com
Summary
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with
severe cancer pain.
Clinical Details
Official title: An Open, Multi-Centre, Non-Comparative Observational Study to Assess the Safety and Tolerability of Oxycodone Injection 50 mg/mL as a Subcutaneous Infusion in Patients With Severe Cancer Pain.
Study design: N/A
Primary outcome: To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
Detailed description:
This is study involving a treatment phase of up to 20 days. During this time patients will
receive Oxycodone Hydrochloride 50mg/ml as a subcutaneous infusion. During the treatment
phase, safety will be assessed by documentation of type and frequency of spontaneously
reported adverse events and adverse events noted after assessment of the infusion site
(every 24 hours and when resited). The subjects will be followed up for 7 days to collect
information on ongoing AEs/SAEs and any new AEs/SAEs that may have occurred.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
1. Male or female subjects aged 18 years and above, who have severe cancer pain.
2. Subjects who require a strong opioid by subcutaneous infusion to stabilise and manage
their cancer pain effectively.
3. Subjects who give written informed consent to participate in the study.
4. Subjects who agree to their primary care physician being informed of their
participation in the study.
5. Subjects who consent to processing of their trial data according to the requirements
of the UK Data Protection Act 1998.
Exclusion Criteria
1. Subjects who are pregnant, lactating or in the Investigators opinion are at risk of
conceiving and are not using adequate contraception measures.
2. Subjects with known hypersensitivity (allergic reaction) to oxycodone, any other
opioids or any of the excipients.
3. Subjects who are planned to receive chemotherapy during the study treatment period or
are currently receiving continuous i. v. chemotherapy infusion.
4. Subjects with neutropenia, thrombocytopenia or coagulation disorders.
5. Subjects with any contraindications to oxycodone as outlined in the Investigator
Brochure or Summary Product Information sheet for oxycodone.
6. Subjects who are currently participating in another clinical research study involving
a new chemical entity.
7. Subjects whom the Investigator believes to be medically unfit to receive the
study medication, or unsuitable for any other reason.
Locations and Contacts
Jill Kiteley, Email: info@contact-clinical-trials.com
Royal Marsden Hospital, London SW3 6JJ, United Kingdom; Recruiting
Julia Riley
Julia Riley, MD, Principal Investigator
Additional Information
Starting date: May 2008
Ending date: May 2009
Last updated: September 8, 2008
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